ONCOLOGISTS’ PERCEPTION OF VALUE

Dr. Peter Neumann of Tufts Medical Center explained that his group at the Center for Evaluation of Value and Risk in Health at the Tufts Institute for Clinical Research and Health Policy Studies was interested in how people used—or perhaps did not use—cost-effectiveness information, how it is communicated, and how it is perceived. The cost-effectiveness literature contains numerous studies in oncology. In 2006, roughly 260 studies that examined cost per quality-adjusted life-year (QALY) were published in the cost-utility literature, and about 30 had applications in oncology (CEVR, 2009). In the literature containing cost-per-life-year studies and similar endpoints outside of oncology, the number is orders of magnitude larger. Many of these studies are in leading medical journals that are widely read by physicians. This raises a question: who is using all of these data, and to what extent are oncologists influenced by costs in their treatment recommendations?

To answer this question, Dr. Neumann, along with Eric Nadler and Benjamin Eckert (Nadler et al., 2006), published a study of 90 oncologists from two leading academic medical centers who responded to a series of survey prompts regarding their views on costs and cost-effectiveness in cancer treatment. The study found that 77.5 percent of oncologists studied agreed that every patient should have access to effective cancer treatments regardless of their costs. Far fewer, only 30 percent, agreed that the costs of

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6
Value in Oncology Practice:
Oncologist and Health Insurer
Perspectives
ONCOLOGISTS’ PERCEPTION OF VALUE
Dr. Peter Neumann of Tufts Medical Center explained that his group
at the Center for Evaluation of Value and Risk in Health at the Tufts Insti-
tute for Clinical Research and Health Policy Studies was interested in how
people used—or perhaps did not use—cost-effectiveness information, how
it is communicated, and how it is perceived. The cost-effectiveness litera-
ture contains numerous studies in oncology. In 2006, roughly 260 studies
that examined cost per quality-adjusted life-year (QALY) were published
in the cost-utility literature, and about 30 had applications in oncology
(CEVR, 2009). In the literature containing cost-per-life-year studies and
similar endpoints outside of oncology, the number is orders of magnitude
larger. Many of these studies are in leading medical journals that are widely
read by physicians. This raises a question: who is using all of these data,
and to what extent are oncologists influenced by costs in their treatment
recommendations?
To answer this question, Dr. Neumann, along with Eric Nadler and
Benjamin Eckert (Nadler et al., 2006), published a study of 90 oncologists
from two leading academic medical centers who responded to a series of
survey prompts regarding their views on costs and cost-effectiveness in
cancer treatment. The study found that 77.5 percent of oncologists studied
agreed that every patient should have access to effective cancer treatments
regardless of their costs. Far fewer, only 30 percent, agreed that the costs of

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ASSESSINg ANd ImPROVINg VAluE IN CANCER CARE
new cancer drugs currently influence their decisions. Eighty-one percent
agreed that patient out-of-pocket therapy costs influence their decisions,
and a similar majority agreed that the costs of new cancer drugs would
impose greater rationing in oncology in the next 5 years (Nadler et al.,
2006). These answers seem to reveal a somewhat conflicted relationship
with treatment costs among these oncologists, reflecting some of the chal-
lenges that oncologists currently face.
The same study posed a series of hypothetical scenarios to the oncolo-
gists surveyed. They were first asked to “Imagine a new cancer medication
for treatment of metastatic lung cancer that on average costs $70,000 more
than standard of care. At what minimum improvement in overall survival
would you prescribe the new medication instead of the standard of care?”
The distribution of responses is shown in Figure 6-1. Even though most
surveyed oncologists agreed that costs should not affect care decisions, a
majority required a minimum 2–4 months added survival to warrant the
$70,000 expense. But there were a few at the extremes, such as one oncolo-
gist who would prescribe the medication for just one day of added survival.
From the average minimum survival benefit required by these oncologists,
Neumann and Nadler derived a mean cost-effectiveness threshold implied
by the oncologists’ responses—$318,000 per life-year gained (Nadler et al.,
2006). The authors concluded that oncologists’ cost-effectiveness threshold
$70,000
50%
Propor tion of Oncologist Respondents
40%
30%
20%
10%
0%
1 day 1 month 2–4 4–6 6–9 9–12 1 year +
months months months months
FIGURE 6-1 Distribution of oncologist responses: hypothetical survival benefit needed
Minimum Overall Survival Benefit
to justify a treatment expense of $70,000.
SOURCES: Neumann presentation, February 9, 2009; Nadler et al., 2006.
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Figure 4-1
vector, fully editable

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VAluE IN ONCOlOgY PRACTICE
for new cancer therapies seem to be high, at least compared to conventional
health care cost-effectiveness thresholds. At the same time, oncologists were
not sure whether expensive new therapies offer good value. After selecting
their minimum survival benefit for an incremental cost of $70,000, the
oncologists were asked “Do you think that reflects good value?” Most said
it did not.
Dr. Neumann explained that he and his colleagues are completing a
follow-up study to determine the extent to which oncologists nationwide
believe that costs influence their prescribing behavior, whether they discuss
costs with patients, and how they feel about various reimbursement policies.
Dr. Neumann concluded that costs seem to influence oncologists’
treatment recommendations, oncologists do not seem to communicate
frequently about costs with their patients, oncologists seem to favor cost-
effectiveness information while wanting to remain in charge of their own
decisions. There also appears to be some enthusiasm among oncologists
for price controls, but most did not favor more cost sharing on the part of
patients. Clearly, costs are a central concern in health care today and there
is a need for better communication between physicians and patients.
PAyING FOR NEW CANCER TREATMENTS: RIGHTS AND
RESPONSIBILITIES OF HEALTH INSURERS
Ever since Benjamin Franklin opened the first fire insurance company,
explained Dr. Newcomer, the responsibility of the insurer has been to spread
risk among a group of people and save them from catastrophic financial
distress. Payors in health care do the same thing: they pool funds among
groups of people so that, when an individual member gets sick, he or she
can pay to treat the illness. Insurers also have a responsibility to maintain
a capital pool that has fiscal integrity. During the 1980s, insurers gained
a third responsibility—that of negotiating on behalf of their members to
find reasonable prices for therapies considered effective. However, the entire
health industry has failed in this third responsibility, with premiums for a
California family of four increasing from only 15 percent of U.S. minimum
wage earnings in 1970 to 101 percent in 20051 (GAO, 1975). The system
1 Figures reflect monthly Federal Employees Health Benefits (FEHBP) total premiums
for the government-wide Blue Cross/Blue Shield options for non-postal workers and mini-
mum wage earnings for full time work of 173.33 hours per month (2,080 hours per year/12)
in California.

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8 ASSESSINg ANd ImPROVINg VAluE IN CANCER CARE
is broken, and we are going to need to do something fairly radical to change
it, Dr. Newcomer said.
Health insurers, or payors, look at value very differently than one
would for FDA studies or phase III randomized controlled trials (RCTs),
as these trials’ results are limited to a very tightly defined group of patients
in controlled treatments. These trials are not the real world. In the real
world, there is what Dr. Newcomer called “the cascade of chaos” during the
dissemination of any new therapy to the nation’s community health care
providers. First, the treatment is approved and promptly used by providers,
often with many errors because they lack experience with the treatment.
Eventually the errors subside as providers become more familiar with the
treatment; they then begin tweaking the indications, and this ultimately
leads to large indication extrapolation and off-label usage. The introduc-
tion of trastuzumab (Herceptin) for HER2-positive breast cancer was no
different. Reddy and colleagues showed that inexperienced community
labs misclassified 15 percent of those told they overexpressed the HER2
gene when they actually underexpressed the gene and had no chance of
responding to trastuzumab. Conversely, 10 percent of those the community
labs said underexpressed the gene actually were overexpressers who should
have been treated but were not (Reddy et al., 2006). To make matters
worse, when oncologists were asked to document HER2 overexpression in
patients receiving trastuzumab, 8 percent of patients being treated showed
no evidence of overexpression, and 4 percent of patients on trastuzumab
treatment had no genetic test results at all. Combining the laboratory errors
and physician misinterpretation of results, the study found over one-third
of patients were receiving the wrong treatment due to inexperience. These
error rates were caused in large part by inexperience reading and reporting
the test results. Before long, oncologists began tweaking the indications for
trastuzumab, bending the limits to treat patients whose overexpression tests
stained at “2+” strength, rather than strictly those whose result was a “3+”
stain. Finally, physicians began to move to off-label uses, such as continuing
trastuzumab treatment through multiple relapses and metastases, despite no
evidence of efficacy to support these uses (Pusztai and Esteva, 2006). The
cascade of chaos has clearly lowered the value of trastuzumab and other
therapies like it in the real world.
Inconsistency in Cancer Treatment
Inconsistency in cancer treatments also reduces value in cancer care even
for well-established therapies. Dr. Newcomer showed a series of pictograph

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VAluE IN ONCOlOgY PRACTICE
grids representing the drug, dose, and schedule regimens of patients with
metastatic breast cancer from practices reimbursed by UnitedHealthcare.
The one thing they had in common was that none of the treatment regi-
mens resembled one another, showing that there was no uniform treatment
of metastatic breast cancer in these community settings. Jack Wennberg also
showed considerable treatment inconsistency when he studied a Medicare
data set to determine health care resources used for patients in the 6 months
before they died, comparing the data across the 77 top hospitals listed in
u.S. News and World Report (Wennberg et al., 2004). There was consider-
able geographic variation in the number of hospital days and physician visits
per patient (Figures 6-2 and 6-3). These data imply that assessments of value
in cancer care using clinical evidence from Palo Alto will be markedly dif-
ferent from the same assessment using clinical evidence from Manhattan.
As a payor, the geographic area one covers will distort the value obtained
for a given service or treatment.
Dr. Newcomer then showed data on inconsistency in cetuximab and
panitumumab treatment for metastatic colon cancer among patients with
UnitedHealthcare coverage. Inexplicably, patients with identical conditions
receiving the same drug had an average of either 5.3 treatment cycles at
$4,428 per cycle at outpatient facilities or 9 cycles at $2,693 per cycle when
treated in the physician’s office. There was no correlation between physician
fee schedule and use of the outpatient facilities. Clearly, there is a great deal
of inconsistency in adult oncology that hampers assessment of its value.
28.0
NYU Medical Center 27.1
24.0
Mount Sinai Hospital 22.8
New York Presbyterian Hospitals 21.6
Cedars-Sinai Medical Center 21.3
20.0
Days
UCLA Medical Center 16.1
16.0
12.0 UCSF Medical Center 11.5
Stanford University Hospital 10.1
8.0
FIGURE 6-2 Days in hospital during the last 6 months of life.
SOURCES: Newcomer presentation, February 9, 2009; Wennberg et al., 2004.
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Figure 4-2

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0 ASSESSINg ANd ImPROVINg VAluE IN CANCER CARE
80.0
NYU Medical Center 76.2
70.0
Cedars-Sinai Medical Center 66.2
60.0
Mount Sinai Hospital 53.9
50.0
Visits
UCLA Medical Center 43.9
New York Presbyterian Hospitals 40.3
40.0
30.0
UCSF Medical Center 27.2
Stanford University Hospital 22.6
20.0
10.0
FIGURE 6-3 Average number of physician visits per patient during the last 6 months
of life.
SOURCES: Newcomer presentation, February 9, 2009; Wennberg et al., 2004.
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Dr. Newcomer’s Proposals for Improving Value in Cancer Care
Figure 4-3
First, Dr. Newcomer said, theawn
redr United States needs its own National
Institute for Health and Clinicalctor, fully editable Eventually, a certain
ve Excellence (NICE).
cost per QALY will have to be set as our cost-effectiveness limit for a treat-
ment, and beyond that we simply cannot cover it in an insurance package.
Second, Dr. Newcomer wondered if a new FDA designation of “scientific
approval” could be created to require new drugs with uncertain economic
benefits to be covered only if the patients receive them in controlled ways
with no off-label uses (while enrolled in registries or trials, for example) to
build scientific evidence for the drug. The drug would then be reevaluated
after 3 years for a final decision. Third, Dr. Newcomer emphasized that
consistent practices across providers and geographies had to be achieved.
He described work he had begun with medical oncology groups who had
decided on their own to go to standardized therapies of their choosing.
These groups are going to be incentivized differently for standardizing
treatments, explained Dr. Newcomer—they will be paid for patient services
rather than based on the drugs they use. UnitedHealthcare plans to observe
these practices and compare outcomes of the standardized treatments they
choose as a type of cluster randomized study. It is hoped that this will
advance best practices faster than RCTs.

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VAluE IN ONCOlOgY PRACTICE
In closing, Dr. Newcomer concluded that the way valuation of treat-
ments occurs must be changed. Compact clinical trials that are currently
used do not represent the actual value of treatments once they reach the
community. The underlying system that assesses value must be changed
because the one we have today doesn’t work.
INTERNATIONAL PERSPECTIVES ON ASSESSING VALUE
FOR ONCOLOGy PRODUCTS
European countries, with all of their variation, differ quite a bit in
their use of oncology products, said Michael Drummond of the Univer-
sity of York. Many eastern European countries, with lower gross domestic
product (GDP) per capita, are quickly adopting modern medicines to keep
pace with the West. The evidence-based medicine approach is common in
northern European countries and gaining ground in southern countries.
Most European health care systems are based on national health services or
social insurance, and hospitals, along with cancer drugs, are funded through
global budgets or case mix-related payments. Health technology assessment
(HTA) is growing and there are many clinical practice guidelines. Recently,
HTA with cost-effectiveness analysis has been used more and more in reim-
bursement and coverage decisions, with the United Kingdom, Netherlands,
Hungary, Belgium, Finland, Norway, Portugal, Sweden, Slovakia, Ireland,
and Germany leading this trend while Spain, Italy, and France consider
whether or not to follow suit.
Cancer drugs account for 10–15 percent of total cancer care expen-
diture, and their costs are increasing 15–20 percent per year. With respect
to expenditure per capita on cancer drugs of different vintages, the United
States shows the highest spending overall and considerable spending on
newer drugs while the United Kingdom shows less overall spending and
very little spending on new drugs (Figure 6-4). Dr. Drummond showed a
series of international comparisons of the uptake of cancer drugs (imatinib,
trastuzumab, cetuximab, and bevacizumab). In each comparison the United
States led all others in uptake and overall usage of the drugs.
The National Institute for Health and Clinical Excellence (NICE) was
created in 1999 as part of the United Kingdom’s National Health Service
(NHS), and it receives funding from the government. Most physicians do
not believe it is independent of the government, and NICE is widely seen
as a rationing body because of its health technology appraisal program,
though it has programs in other areas such as public health interventions,

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ASSESSINg ANd ImPROVINg VAluE IN CANCER CARE
40
2003–200 4
35 2000–200 2
1995–199 9
30
<1995
25
20
15
10
5
0
United States
France
Japan
Switzerland
Austria
Belgium
Finland
Germany
Sweden
Spain
Italy
Denmark
Netherlands
Canada
Norway
Australia
Hungary
United Kingdom
Czech Republic
New Zealand
Poland
South Africa
SA Insured pop.
All countries
FIGURE 6-4 Adjusted per capita cancer drug sales (€) in 22 countries, by drug-release
year (2005 data).
SOURCES: Drummond presentation, February 9, 2009; Jonsson and Wilking, 2007;
based on IMS Health, IMS MIDAS Quantum (for South Africa, sales per capita is
R01506
presented along with two capita rates for the total population as well as for the insured
Figure 4-4
[18.5%] population).
vector, fully editable
new investigational procedures, and clinical guideline development. Also,
the program takes care to appraise both a treatment’s clinical effectiveness
and its cost-effectiveness. The health technology appraisal program has two
tracks:
1. Multiple technology appraisal (MTA) is a full systematic review and
economic analysis performed by independent centers (mostly aca-
demic) of several drugs in a treatment class or several technologies
simultaneously. It requires 54 weeks.
2. Single technology appraisal (STA) was introduced as a fast-track
appraisal process. STA is not an independent appraisal but a detailed
analysis of a drug company’s submitted analysis without external
review. It requires 39 weeks. To date, almost all of the drugs that
have gone through STA have been cancer treatments.

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VAluE IN ONCOlOgY PRACTICE
The health technology appraisal program at NICE has also employed
a cost-effectiveness threshold of £20,000 to £30,000 per QALY gained, or
roughly $30,000 to $50,000 per QALY (at the time of the workshop), for
approval. Above this threshold, drugs are unlikely to be approved for use
by the NHS.
Dr. Drummond presented his research on NICE guidance regarding
new cancer drugs appraised between May 2000 to March 2008. Data were
extracted from published NICE technology appraisals and eventual licen-
sure in the United Kingdom NICE drug appraisal outcomes were classified
for each indication at one of three levels: (1) no restrictions for use in the
NHS per the drug’s license, (2) no routine use (the drug is banned from
NHS use altogether), or (3) restricted use only under certain circumstance,
for certain patients, or in certain clinical indications narrower than the
license. Of the 55 treatments appraised, 30 (55 percent) were approved
without restrictions on their license, 16 (29 percent) were approved with
restrictions, 8 (15 percent) were given no routine use, and one (2 per-
cent) was not licensed (Mason and Drummond, 2008). Drugs that were
restricted were most often approved for only a particular subset of patients.
Alternatively, they were limited to use only in patients who responded while
on them, as first- or second-line therapy only, or in patients who had not
previously tried them. Reasons for these restrictions varied (Figure 6-5),
and included insufficient evidence of effectiveness, methodological issues
in economic analyses, uncertainty concerning the evidence submitted for
the appraisal, an incremental cost-effectiveness ratio (ICER) that did not
clearly meet NICE criteria, or an ICER that was too high.
Recent Controversy Surrounding NICE
NICE recently appraised several new drugs for treating renal carcinoma
and recommended that none of them be used by the NHS because of
poor cost-effectiveness.2 There was uproar as a result, with oncologists and
patients outraged that the drugs were not offered in the United Kingdom
but were readily available in other countries. While there was speculation
that NICE had become overly stringent in its decisions, Dr. Drummond
2Versus interferon alpha, one drug (sunitinib) cost £71,462 per QALY (£31,185 for
0.44 QALYs gained), a second (bevacizumab) cost £171,301 per QALY (£45,435 for 0.27
QALYs gained), and a third (temsirolimus) cost £94,385 per QALY (£22,272 for 0.24 QALYs
gained) (NICE, 2008).

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vector, fully editable
landscape above, scaled for por tait below
ASSESSINg ANd ImPROVINg VAluE IN CANCER CARE
100%
90%
80%
Percent of drug evaluations
70%
60%
50%
40%
30%
20%
10%
0%
Evidence ICER explic it ICER: lack Method ological Insu fficient Uncertainty
ICER reason for evidence of
of evidence issues issues
too high restriction effectiveness
FIGURE 6-5 Reasons for NICE restrictions by percent of drug evaluations, May 2000
through March 2008 (n = 24).
SOURCES: Drummond presentation, February 9, 2009; Mason and Drummond,
2008.
explained that NICE had not changed its criteria at all. Instead, the cost of
drugs submitted for appraisal had increased, and a greater number exceeded
the cost-effectiveness threshold (Mason and Drummond, 2008).
These controversies surrounding NICE pose important questions:
1. How did NICE arrive at the threshold, and is the threshold at the
correct cost-effectiveness level?
2. Are oncology drugs special in some way that should exempt them
from NICE rules?
Regarding the first question, Dr. Drummond explained that the thresh-
old is not based on research. Analysis of current cancer care expenditures
in the NHS has found that the health service spends about £13,000 for
every QALY gained—much less than the threshold (Martin et al., 2007).
Ongoing research in the United Kingdom population is examining what the
public thinks a QALY is worth and whether it is worth the same amount
in different circumstances.
Regarding whether cancer drugs should be exempt from NICE rules,
there has been a major development. Treatments can now qualify for what
is called “supplementary guidance for end-of-life therapies” only if they
are indicated for a small patient population with a life expectancy less than
24 months, if no equivalent active therapy exists, and if they would add
at least three months to patients’ life expectancy. For drugs recommended

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VAluE IN ONCOlOgY PRACTICE
for approval in this manner, the QALYs gained assume full quality of life
in the added months. Also, NICE’s Appraisal Committee can take the
view that, when adjusted this way, the QALYs gained at the end of life as a
result of the treatment should be weighted highly enough for the therapy
to be considered cost-effective when judged against the institute’s existing
cost-effectiveness threshold for approval. This compromise is based on the
understanding that QALYs are worth more to those who have less time to
live, or those who are very unfortunate health-wise. The application of this
new guidance has led to approval of the drugs for renal cancer that were
initially declined, although there were also additional negotiations between
NICE and the manufacturers that contributed to this change.
Another approach has been the establishment of performance-related
contracts, such as that for Velcade (bortezomib). During Velcade’s tech-
nology appraisal, which appeared not to be going as well as hoped, the
manufacturer approached NICE and offered to provide credit to the
NHS for those patients who did not show a clinical response to the drug.
Other manufacturers have done the same to try to reduce concerns among
payors.
Dr. Drummond concluded that there is considerable variation across
Europe both in access to drugs and the extent to which they are assessed
for value. However, assessments like those performed by NICE are widely
used in drug formulary listings and the assessments do lead to restrictions
in the use of medications. There are two key issues: what is considered good
value for the money, and whether cancer should be treated differently from
other diseases.
DISCUSSION
Dr. Bhadrasain Vikram of the National Cancer Institute asked Dr.
Newcomer why, with the huge data he had available to him at United-
Healthcare, he did not simply perform his own NICE-like scientific
approval designation. Dr. Newcomer explained that the insurance regula-
tions in the United States vary from state to state, and this introduces many
barriers to implementing uniform coverage decisions. He had found it very
difficult to mandate that UnitedHealthcare not cover a drug because of
expense or equivocal evidence.
Dr. John Mendelsohn of the M.D. Anderson Cancer Center asked
whether NICE’s guidance was only for the NHS or whether it also applied
to the United Kingdom’s private sector as well. Dr. Drummond explained

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ASSESSINg ANd ImPROVINg VAluE IN CANCER CARE
that it applied almost entirely to the NHS because few of the technologies
NICE has examined impact the largest applications of private health insur-
ance in the United Kingdom, such as outpatient surgery, and few private
payors followed the NHS’ coverage decisions in the same way private pay-
ors in the United States follow decisions of the Centers for Medicare and
Medicaid Services (CMS).
Dr. Robert Mass of Genentech asked how NICE integrates the value
of innovation into its equation when assessing novel drugs. Dr. Drummond
said that it was clearly in the guidance for the NICE committee to consider
innovation in the drugs they assess, but many decisions revolve around the
cost-effectiveness threshold. The French system, he said, has gone further
toward pricing drugs based on their level of innovation. Dr. Neumann
added that Medicare’s national coverage decisions seem to be moving in
the direction of considering innovation but hinge centrally on clinical out-
comes. He noted that a treatment can be very innovative without necessarily
being good value.
Dr. Tunis recalled while at CMS that he had seen data to suggest
oncologists prescribe chemotherapy to increase personal income. He asked
Dr. Neumann whether a self-report survey such as his could actually provide
insights into personal revenue-driven prescribing. Dr. Neumann said that
he and his colleagues tried to address this issue a number of ways, asking
such questions in the survey as “To what extent have Medicare rules on
oral chemotherapy limited your prescribing?” Around 60 percent said the
Medicare rules had limited their prescribing. Dr. Neumann said the survey
also asked oncologists whether they thought physicians in their profession
made too much money. Few thought so. Dr. Neumann reported that he
and his colleagues had also tried to identify the subset of respondents in
practice settings with greater opportunity to make money by prescribing.
Unfortunately, this was hard to tease out. Dr. Newcomer recalled an article
in Health Affairs that suggested oncologists were not prescribing just to
make money when there was not a reasonable indication, though they were
maximizing revenue by choosing the more expensive regimen when they
had multiple options (Jacobson et al., 2006).
Dr. Sargent was careful to note that Dr. Newcomer’s standardization of
practices was not a true cluster randomization design because there was no
embedded randomization step. Dr. Sargent suggested that Dr. Newcomer
introduce some element of randomization to the process and encour-
aged him to do some type of matching so that the study groups could be
compared in valid ways. Dr. Newcomer agreed with these points. His first

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priority, though, was to encourage standardization of treatments because
this alone could dramatically improve outcomes.
Dr. Mendelsohn pointed out that it should be the patient who decides
the therapies she or he will receive. The physician is ethically required to
present a balanced recommendation for therapy, but the physician cannot
make the ultimate decision. Dr. Neumann agreed and added that more
research was needed on how people think about small probabilities of large
gains and how this influences their decisions.
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